Process Engineer - Asset Delivery IDM

Role Summary

Process Engineer - Asset Delivery IDM at Lilly with responsibilities for developing, designing, qualifying/validating and delivering automated device assembly equipment for IDM globally, including support for returning lines to service and optimizing lines at Lilly sites and Contract Manufacturers. Collaborates with IDM team members and OEMs to design and build custom medical device assembly machines. Travel is required.

Responsibilities

• Technical Proposal Assessment: Assess technical proposals from original equipment manufacturers (OEM)
• User Requirements: Generate user requirements for each project asset
• pFMEA Develop: Manage to identify and mitigate technical and patient risks
• Design Reviews: Conduct detailed review sessions with OEMs and project teams to ensure design aligns with all requirements and conforms to local/corporate standards
• OEM Design Documentation: Verify documentation is comprehensive, complete and accurately represents the specifications of the equipment
• Key Control Parameters: establish through the Engineering Studies Plan
• Engineering Studies Protocol: Develop and implement summarized protocols in reports for verification testing
• User Requirements: Develop and perform testing to verify
• Performance Improvements: Identify opportunities to optimize equipment
• Safety Risks: Assess, document and engage in HSE walkdowns
• Maintenance Plan: Work with OEM and local site to develop the plan
• Engineering Tools: Utilize Design of Experiments (DOE), Gauge Repeatability & Reproducibility (GR&R), and statistical methods for conducting engineering studies and preparing reports
• Change Management: Document all project changes and adhere to formal change management procedures
• Receiving Site Collaboration: ensure equipment is production ready
• Design Consideration Verification Checklist: Assist in developing the checklist

Qualifications

• BS in an Engineering (Electrical, Mechanical, Chemical, or Biomedical Eng preferred)
• Minimum 2 years engineering experience, preferably in medical device, pharmaceutical, or related industry working with high speed, discrete mechanical/process assembly & packaging equipment
• Experience in capital project delivery

Additional Preferences

• Medical Devices experiences preferred
• Experience working with automated manufacturing equipment
• Engineering in regulated pharmaceutical environments (cGMPs/Commissioning and Qualification)
• Large capital project delivery and sub-project management
• DOE and statistical methods in engineering
• Experience with vision systems for part inspection and debugging of assembly equipment
• Eager to support and lead team efforts while learning

Skills

• High initiative, ownership, and accountability
• Strong communication, teamwork, and networking
• Solid technical writing
• Organization and prioritization of multiple tasks
• Attention to detail
• Problem-solving
• Ability to work independently and in teams
• Ability to lead and influence across organizational and company boundaries
• Ability to form and foster relationships with others not in your organization

Additional Requirements

• Ability to travel 25% on average, with peaks over 50% for a few months at a time